Table 3.

Verification in practice.

Documentation you can expect	Manufacturer should provide evidence of their BioMeT’s: • Performance specifications for the integrated hardware • Output data specifications • Overview of software system tests • Limitations to the verification testing • e.g., specific known items that were not tested during verification
Clinical users’ questions answered by verification	Is the performance of this BioMeT and each of its components sufficient to generate sample-level data of acceptable quality such that it can be used as an input to generate the processed data and downstream clinical measurement that I am interested in?